NCT06796322 Clinical Evaluation of Non-invasive Blood Glucose Meter
| NCT ID | NCT06796322 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2025-01-01 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial is a prospective, multicenter, non-randomized, open-label, self-controlled, paired design clinical study, which will be conducted in 3 research centers, with a total of 210 subjects enrolled, including diabetic patients aged 18 years and above and some healthy subjects. After screening, each eligible subject will have their blood glucose measured simultaneously at specified time points using three methods: non-invasive blood glucose meter (the experimental group), fully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose, and fingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose. The aim of this trial is to evaluate the efficacy and safety of the non-invasive blood glucose meter for blood glucose measurement in diabetic patients.
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria for healthy subjects: * Male or female, aged \>=18 years. * Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form. Inclusion Criteria for patients with type 2 diabetes: * Male or female, aged \>=18 years. * Previously diagnosed type 2 diabetes according to WHO criteria of 1999. * Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form. Exclusion Criteria: Exclusion Criteria for healthy subjects: * There are injuries, scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested. * Allergy to lasers. * Had diabetes history or fasting blood glucose (FPG) \>= 6.1 mmol/L or glycated hemoglobin (HbA1c) \>= 5.7% during the screening period. * Alcohol dependency or drug abuse. * Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial). * Pregnancy or lactation period. * Difficulty in venous blood collection or fainting of needles or blood. * Other circumstances that the investigator considers inappropriate to participate in the study. Exclusion Criteria for patients with type 2 diabetes: * There are injuries, scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested. * Allergy to lasers. * Type 1 diabetes, monogenic mutant diabetes, pancreatic damage, or secondary diabetes of other causes should be excluded. * Severe structural heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, chronic congestive heart failure (NYHA≥III); acute myocardial infarction within 12 months before enrollment; history of severe liver or kidney dysfunction (eGFR \< 60 ml/min/1.73m2 calculated by MDRD formula at screening period); and mental disorders, etc. * With a history of acute complications of diabetes within 3 months before enrollment; or severe diabetes-related complications. * Alcohol dependency or drug abuse. * Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial). * Pregnancy or lactation period. * Difficulty in venous blood collection or fainting of needles or blood. * Other circumstances that the investigator considers inappropriate to participate in the study.
Contact & Investigator
Weiqing Wang, Dr.
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT06796322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06796322 currently recruiting?
Yes, NCT06796322 is actively recruiting participants. Contact the research team at feifei-a@163.com for enrollment information.
Where is the NCT06796322 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06796322 clinical trial?
NCT06796322 is sponsored by Shanghai Jiao Tong University School of Medicine. The principal investigator is Weiqing Wang, Dr. at Ruijin Hospital. The trial plans to enroll 210 participants.
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